Clean Utilities Engineer

Technical Source; North Carolina; On-site; USD 90,000 - 120,000; Full time

Job summary

Technical Source seeks an experienced Clean Utilities Engineer to support utility and facility systems within a GMP-regulated pharmaceutical manufacturing environment in North Carolina. This role provides hands-on engineering and field support for operation, troubleshooting, maintenance, and improvement of critical utility systems.

Ideal candidate holds a Bachelor's degree in Mechanical, Electrical, Industrial, or Chemical Engineering with 5–10 years of GMP utilities experience, and strong

Qualifications

• Hands-on troubleshooting and maintenance of utility equipment in a GMP manufacturing setting.
• Familiarity with WFI, PW, RO, clean steam and process gases.
• Experience with cleanroom HVAC, AHUs, and related controls.
• Knowledge of GMP documentation, deviations, CAPAs, investigations, and root-cause analysis.

Responsibilities

• Provide technical and field support to Maintenance and Operations teams for troubleshooting, testing, maintenance, and daily utility operations.
• Support clean utilities, including WFI, purified water (PW), RO, clean steam, and process gases.
• Support plant utilities, including HVAC, chilled water, boilers, compressed air, and vacuum systems.
• Troubleshoot equipment issues, alarms, and system performance problems and support root cause investigations and corrective actions.
• Work with cross-functional teams to ensure GMP-compliant operations.

Skills

Troubleshooting

Maintenance planning

Cross-functional collaboration

Regulatory compliance

Root cause analysis

Education

Bachelor's degree in Mechanical, Electrical, Industrial, or Chemical Engineering

Tools

HVAC systems

GMP documentation

Process gases handling

Job description

We are seeking an experienced Clean Utilities Engineer to support utility and facility systems within a GMP-regulated pharmaceutical manufacturing environment. This role provides hands-on engineering and field support for the operation, troubleshooting, maintenance, and improvement of critical utility systems.

Key Responsibilities

• Provide technical and field support to Maintenance and Operations teams for troubleshooting, testing, maintenance, and daily utility operations.
• Support clean utilities, including WFI, purified water (PW), RO, clean steam, and process gases.
• Support plant utilities, including HVAC, chilled water, boilers, compressed air, and vacuum systems.
• Troubleshoot equipment issues, alarms, and system performance problems and support root cause investigations and corrective actions.
• Provide engineering support for cleanroom HVAC, including AHUs, pressure cascades, airflow, temperature/humidity control, HEPA filtration, and environmental conditions.
• Support preventive and predictive maintenance programs, PM optimization, reliability improvements, spare-parts planning, and equipment lifecycle strategies.
• Support deviations, change controls, CAPAs, investigations, and technical assessmentsrelated to utility and facility systems.
• Support utility and facility projects, including upgrades, remediation, capacity expansions, design reviews, risk assessments, commissioning, qualification, and requalification.
• Work closely with Maintenance, Manufacturing, Validation, Quality, Automation, EHS, contractors, and vendors to ensure safe, reliable, and GMP-compliant operations.

Qualifications

• Bachelor's degree in Mechanical, Electrical, Industrial, Chemical Engineering, or a related engineering discipline.
• 5-10 years of utilities or facilities engineering experience in pharmaceutical, biotechnology, CDMO, or another GMP-regulated manufacturing environment.
• Hands-on experience testing, troubleshooting, and diagnosing utility systems and equipment in an operating manufacturing facility.
• Strong knowledge of WFI, PW, RO, clean steam, process gases, HVAC, and plant utilities.
• Experience with cleanroom HVAC systems, including AHUs, pressure cascades, airflow, temperature/humidity control, and HEPA filtration.
• Experience with GMP documentation, deviations, change controls, CAPAs, investigations, and root cause analysis.
• Experience supporting maintenance/reliability programs, commissioning, qualification, system upgrades, and utility lifecycle activities.
• Working knowledge of GMP requirements, ALCOA+ data integrity principles, QMS systems, and pharmaceutical regulatory expectations.